Recall Z-2949-2020 ยท EOQ Bronchoscope (Flexible Or Rigid)
Intuitive Surgical, Inc.
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
| Date | Jun 10, 2020 |
| Status | Open, Classified |
| Reason | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System. |
| Root cause | Device Design |
| Action | The firm notified their consignees regarding the "Urgent Medical Device Recall" notification via Fedex, and issued on 06/10/2020. The actions to be taken by the Customer/User are as follows: Locate the affected product at the site and return to the recalling firm via the standard RMA process. As part of the standard field action process, please take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform necessary personnel when corrective action has been completed. 3. Complete the Acknowledgement Form and return to the recalling firm as instructed on the form |
| Quantity | 67 units |
| Distribution | U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle Intuitive Surgical, Feb 14, 2019 |